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2026 Budget Law Reshapes Orphan Drug Exclusivity and Reopens Competition
Section 6605 of the 2026 Consolidated Appropriations Act requires the FDA to retroactively review active orphan drug exclusivities, potentially narrowing protections for high-revenue products and reopening approval pathways for pediatric and subpopulation-specific therapies previously blocked under disease-wide interpretations. Image: 123rf
Congress enacted the 2026 Consolidated Appropriations Act (CAA) on February 3, 2026, delivering a significant legislative fix for the pharmaceutical industry. Section 6605 of the …
2026 Budget Law Reshapes Orphan Drug Exclusivity and Reopens Competition Read More »
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